MAUDE manufacturer profile

GREINER BIO-ONE GMBH · FMI

MAUDE profile for Needle, Hypodermic, Single Lumen

Key facts

Manufacturer GREINER BIO-ONE GMBH
Manufacturer group GREINER BIO-ONE NA INC.
Product code FMI
Product code name Needle, Hypodermic, Single Lumen

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Needle Stick/Puncture, Detachment of Device or Device Component, Break, Fail-Safe Problem, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Material Twisted/Bent Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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